Feasibility of a health behaviour change intervention- PAD patients-
Research type
Research Study
Full title
Feasibility of a multi site RCT to establish the effectiveness of a health behaviour change intervention for patients with Peripheral Arterial Disease (PAD).
IRAS ID
240417
Contact name
Mary McCallum
Contact email
Sponsor organisation
NHS Grampian
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
The aim of this study is to assess the feasibility of conducting a multi-centre trial of a specially designed health behaviour change intervention delivered in a clinical setting to improve functional walking ability for patients with Peripheral Arterial Disease (PAD). This feasibility study, based on the MRC framework will assess the relative strengths and weaknesses of the intervention and study design and pave the way for a more definitive trial. It is an important area of research as approximately 20% of the UK population aged 55-75 have PAD. It is caused by narrowing of the arteries causing poor blood flow which can lead to serious health implications including heart attack, stroke, renal artery disease and amputation.The principle risk factor in the development of PAD is smoking, other modifiable risk factors include hypertension, high cholesterol, diabetes and sedentary lifestyle.\nResearch evidence highlights around 50% of referrals for PAD could be equally as well managed through changes in health behaviour as formal medical or surgical treatment. In this feasibility study we will recruit 50 patients newly diagnosed with PAD, randomised into two groups. The control group will receive usual care, including signposting to opportunities to be active and smoking cessation services. The treatment group will receive usual care and a health behaviour change intervention which will include sessions with a Health Psychologist to develop a tailored plan for each participant with follow up and support. Each group will have measures taken at baseline, 3 and 6 months to record change in functional walking ability. We will also record any changes in weight and number of cigarettes smoked and any change in questionnaire scores relating to quality of life, anxiety and depression.
REC name
North of Scotland Research Ethics Committee 1
REC reference
19/NS/0003
Date of REC Opinion
4 Feb 2019
REC opinion
Favourable Opinion